Obstetrics: Mid Trimester Miscarriage and Preterm Birth Pregnancy and Childbirth
Conditions
Interventions
Women will be randomised via a web based application provided by the Birmingham Clinical Trials Unit.
Women will be randomised to rescue cerclage, an emergency cervical cerclage performed as quickly
Sponsors
Birmingham Women's and Children's NHS foundation trust.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or older 2. Cervical dilatation with exposed, unruptured foetal membranes 3. Singleton pregnancy 4. Gestational age 16+0 to 27+6 weeks 5. Able to give informed written consent
Exclusion criteria
Exclusion criteria: 1. Contraindication to rescue cerclage as judged by the clinician 2. Cervical cerclage (vaginal or abdominal) inserted earlier in this pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy loss rate (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal (from medical records): 1. Time from conception to pregnancy end (any reason) 2. Miscarriage and pre-viable neonatal death (defined as delivery =24 weeks) 4. Gestation at delivery (in live births >= 24 weeks ) 5. Gestational age = 24 weeks) 6. Time from conception to onset of spontaneous vaginal delivery (in live births >= 24 weeks) 7. Sepsis (at any time in pregnancy and until 7 days postnatal) 8. Preterm pre-labour rupture of membranes (PPROM) 9. Gestational age at PPROM 10. Mode of initiation of labour (spontaneous or induced) 11. Mode of delivery (vaginal or operative vaginal or caesarean) 12. Cerclage placement complications (cervical laceration/bleeding from cervix/ruptured membranes/bladder injury) 13. Cerclage removal complications (cervical tears/need for anaesthetic/difficult to remove) 14. Other maternal complications: vaginal bleeding/steroid use/chorioamnionitis/maternal pyrexia of 38°C (intrapartum/postnatal)/systemic infection requiring antibiotics (intrapartum/postnatal)/admission to HDU or ITU (pre/post-delivery) 15. Serious adverse events Neonatal (from medical records): 16. Early neonatal death (defined as a death within 7 days after delivery ) 17. Late neonatal death (defined as a death beyond 7 days and before 28 days after delivery) 18. Birth weight adjusted for gestational age and sex (in live births >= 24 weeks) 19. Small for gestational age and sex (= 24 weeks) 20. Resuscitation at birth/additional care required (SCBU/NICU/HDU/transitional)/length of stay in additional care 21. Antibiotics within 72 hours/sepsis (clinically diagnosed/proven) 22. Early neurodevelopmental morbidity (severe abnormality on cranial ultrasound scan) 23. Respiratory support (ventilation/CPAP)/days on respiratory support/supplementary oxygen requirements at 36 weeks post-menstrual age 24. Necrotising enterocolitis (Bell’s stage 2 or 3) 25. Retinopathy of prematurity requiring laser treatment/disabilities/congenital abnormalities 26. Serious adverse eve | — |
Countries
England, United Kingdom
Outcome results
None listed